Manager, Patient Safety Scientist

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction:

The Manager, Patient Safety Scientist is an entry level role which supports the Global Safety Physician (GSP) and (Senior/Principal) PV Scientist with the review of safety data and related documents to identify and escalate potential safety issues. He/she has the ability to provide the first draft of safety documents and regulatory reports, and will participate in meetings, as necessary.

Main Responsibilities:

• Supports proactive pharmacovigilance and risk management planning for designated products, including project managing preparation of the safety aspects of the global Risk Management Plans, in partnership with the Global Safety Physician (GSP) and (Senior/Principal) PV Scientist, as appropriate.
• Provides patient safety input to pivotal study documents, for example Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Runs/supports routine signal detection processes in partnership with the GSP, for all products in area of responsibility.
• Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals. Creates first draft of documents with clear conclusions in response to internal or regulatory authority requests for safety data.
• In consultation with the GSP and Clinical representatives, drafts the Reference Safety Information (RSI) for assigned development products; coordinates meetings and tracks timelines to ensure completion. Provides input to periodic regulatory documents (e.g. PBRERs, PSURs, and DSURs) according to the agreed processes and timelines.
• Provides patient safety input to the global regulatory submissions for new products, formulations or indications (e.g. NDA, BLA, MAA), in partnership with GSP and (Senior/Principal) PV Scientist and in liaison with other functional experts.
• Raises appropriate concerns/issues to senior staff in a timely manner.

Education and Experience:

• A life sciences/pharmacy/nursing degree, and advanced Patient Safety and/or Clinical/ Drug Development knowledge and experience.
• Fluent in written and verbal English
• Awareness of Pharmacovigilance regulations
• MD, MSc/PhD in scientific discipline

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.